FDA 510(k)

Erbe APCapplicators

Número K: K183445 · 2019-04-04

Data da decisão2019-04-04

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Erbe APCapplicators is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K183445. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Erbe APCapplicators?

Erbe APCapplicators is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K183445.

When did Erbe APCapplicators receive FDA 510(k) clearance?

Erbe APCapplicators received FDA 510(k) clearance on 2019-04-04, under 510(k) number K183445.

Who is the listed applicant for Erbe APCapplicators?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erbe APCapplicators?

The FDA product code for Erbe APCapplicators is GEI.

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Fonte oficial

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